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临床试验/NCT03223389
NCT03223389Unknown不适用

Effects of Fat Metabolites on Gut Hormone Secretion After Gastric Bypass Surgery

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Within group difference in Gastric Inhibitory Peptide (GIP) secretion (evaluated by AUC above basal).

研究概览

简要总结

To investigate the effects of different fat metabolites on gut hormone secretion in gastric bypass operated subjects and BMI-matched controls.

详细描述

Dietary triglycerides are hydrolyzed during digestion to two fatty acids and one 2-monoacyl glycerol. The study will investigate the effects of these different fat components on gut hormone secretion in gastric bypass operated patients and non-operated BMI-matched controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Uncomplicated gastric bypass surgery performed minimum 12 months prior to study

排除标准

  • Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
  • Pregnancy or breastfeeding
  • Haemoglobin levels below 6,5 mM
  • Gall bladder removal
  • Healthy control subjects:
  • Exclusion Criteria:
  • Bariatric surgery or complicated upper abdominal surgery
  • Gall bladder removal
  • Pregnancy or breastfeeding
  • Haemoglobin levels below 6,5 mM
  • Co-morbidities or medicine significantly affecting glucose metabolism or appetite regulation

研究组 & 干预措施

10 gastric bypass operated patients

Experimental

3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.

干预措施: Tricaprylin (Dietary Supplement)

10 healthy control subjects

Experimental

3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.

干预措施: Olive oil (Dietary Supplement)

10 gastric bypass operated patients

Experimental

3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.

干预措施: C-8 dietary oil (Dietary Supplement)

10 healthy control subjects

Experimental

3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.

干预措施: C-8 dietary oil (Dietary Supplement)

10 healthy control subjects

Experimental

3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.

干预措施: Tricaprylin (Dietary Supplement)

10 gastric bypass operated patients

Experimental

3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.

干预措施: Olive oil (Dietary Supplement)

结局指标

主要结局

Within group difference in Gastric Inhibitory Peptide (GIP) secretion (evaluated by AUC above basal).

时间窗: 0-240 min following fat ingestion.

Comparison of the GIP responses (evaluated by AUC above basal) induced by the different oils.

Within group difference in cholecystokinin (CCK) secretion (evaluated by AUC above basal).

时间窗: 0-240 min following fat ingestion.

Comparison of the CCK responses (evaluated by AUC above basal) induced by the different oils.

Within group difference in glucagon-like peptide-1 (GLP-1) secretion (evaluated by AUC above basal).

时间窗: 0-240 min following fat ingestion.

Comparison of the GLP-1 responses (evaluated by AUC above basal) induced by the different oils.

次要结局

  • Responses (evaluated by AUC above basal) of C-peptide within and between groups.(0-240 min following fat ingestion.)
  • Responses (evaluated by AUC above basal) of fibroblast growth factor 19 (FGF-19) within and between groups.(0-240 min following fat ingestion.)
  • Responses (evaluated by AUC above basal) of peptide YY (PYY) within and between groups.(0-240 min following fat ingestion.)
  • Responses (evaluated by AUC above basal) of glucagon within and between groups.(0-240 min following fat ingestion.)
  • Responses (evaluated by AUC above basal) of lipid metabolites (triglyceride, cholesterol, fatty acids) within and between groups.(0-240 min following fat ingestion.)
  • Responses (evaluated by AUC above basal) of neurotensin within and between groups.(0-240 min following fat ingestion.)
  • Between group comparison of GLP-1 secretion (evaluated by AUC above basal).(0-240 min following fat ingestion.)
  • Responses (evaluated by AUC above basal) of bile acids within and between groups.(0-240 min following fat ingestion.)
  • Responses (evaluated by AUC above basal) of glucose within and between groups.(0-240 min following fat ingestion.)
  • Between group comparison of differences in CCK secretion (evaluated by AUC above basal).(0-240 min following fat ingestion.)
  • Between group comparison of GIP secretion (evaluated by AUC above basal).(0-240 min following fat ingestion.)
  • Between group comparison of CCK secretion (evaluated by AUC above basal).(0-240 min following fat ingestion.)
  • Responses (evaluated by AUC above basal) of insulin within and between groups.(0-240 min following fat ingestion.)
  • Responses (evaluated by AUC above basal) of oxyntomodulin within and between groups.(0-240 min following fat ingestion.)
  • Between group comparison of differences in GLP-1 secretion (evaluated by AUC above basal).(0-240 min following fat ingestion.)
  • Between group comparison of differences in GIP secretion (evaluated by AUC above basal).(0-240 min following fat ingestion.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoffer Martinussen

Medical doctor

Hvidovre University Hospital

研究点 (2)

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